Does Intraoperative Clonidine Reduce Post Operative Agitation in Children?

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Clonidine is widely used off-label in children for several indications. Clonidine is used for treatment and/or prevention of postoperative agitation in children anaesthetised with Sevoflurane. The investigators don´t have solid evidence for the effect and the investigators don´t have data for characterization of the pharmacokinetic profile among age-groups for children 1-6 years.

In this study the investigators want to investigate if IV Clonidine administered at the end of surgery can prevent/reduce postoperative agitation. Secondary outcomes include measurements of postoperative pain relief and adverse effects, including a 30-day follow-up.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Treatments: Clonidine; Sevoflurane

Criteria

Inclusion Criteria:

• scheduled for surgery with Sevoflurane as the choice of anesthesia.

Exclusion Criteria:

• ASA classification >2

• Premedication with Clonidine

• Ex-premature (born before week 37+0 AND <60 weeks old)

• Intubated before anaesthesia and/or no plans for extubation after anaesthesia.

• Critical illness with haemodynamic instability.

• Active bleeding.

• Cancer.

• Cardiac diseases including arrhythmias.

• Malignant hyperthermia.

• Mental retardation.

• Neurological illness with agitation-like symptoms.

• Weight >50 kg.

• Allergy to Clonidine.

• Patients treated with methylphenidate / Concerta.